Camupepimut did not improve disease-free survival versus observation in pancreatic cancer in the randomized phase 2 AMPLIFY-7P trial

1. Camupepimut did not meet the primary disease-free survival endpoint versus standard-of-care observation: median 23.8 versus 21.2 months; HR 0.85, P = 0.5329.

2. Grade ≥3 adverse events occurred in 10.4% with camupepimut and 14.6% with observation; overall survival data were not mature.

Evidence Rating Level: 2 (Good)

2MM Brief: Pancreatic ductal adenocarcinoma frequently recurs after locoregional treatment, and the AMPLIFY-7P trial evaluated a lymph node-targeted vaccine for patients with KRAS-mutated disease. George and colleagues conducted an open-label, randomized phase 2 trial in 144 adults with stage I-III pancreatic adenocarcinoma who had undergone standard locoregional therapy and had no radiographic recurrence within 6 months. Participants were randomized 2:1 to camupepimut (ELI-002 7P; n = 96) or standard-of-care observation (n = 48), with a median follow-up of 19.4 months. The primary investigator-assessed disease-free survival endpoint was not met: median disease-free survival was 23.8 months with camupepimut versus 21.2 months with observation (HR 0.85, P = 0.5329); a confidence interval was not reported in the abstract. A prespecified analysis during the dosing period showed 6-month disease-free survival of 75.7% versus 61.7%, with HR 0.55 and P = 0.0557. A post hoc multivariate analysis suggested improved disease-free survival with camupepimut (adjusted HR 0.47, P = 0.0086), while stage III disease, elevated baseline CA19-9 and baseline circulating tumor DNA positivity were associated with worse outcomes. In an exploratory analysis, 98.9% (89/90) of evaluable patients developed ex vivo mKRAS-specific T-cell responses, and responses greater than 9.17-fold over baseline correlated with improved disease-free survival (HR 0.22, P < 0.0001); these immune-response analyses were not randomized treatment comparisons. Grade ≥3 adverse events occurred in 10.4% (10/96) of camupepimut-treated patients and 14.6% (7/48) of observation patients, while serious adverse events occurred in 6.3% (6/96) and 8.3% (4/48), respectively. Overall survival data were not mature, and tumor biomarker and crossover analyses were ongoing. The trial was open-label, and several favorable analyses were post hoc or exploratory. These findings do not establish a disease-free survival benefit for camupepimut, although the reported immunogenicity and exploratory signals may inform further study.

Click here to read the study in Nature Medicine

Citation: George B, Singh H, Devoe CE, Chung V, Hosein PJ, Hendifar A, et al. Lymph node-targeted, mKRAS-specific amphiphile vaccine in pancreatic cancer: the randomized phase 2 AMPLIFY-7P trial. Nat Med. 2026 Oct 23. doi: 10.1038/s41591-026-04734-7. Epub ahead of print. PMID: 42919966.

© 2026 2 Minute Medicine, Inc. All rights reserved. No part of this article may be reproduced, distributed or transmitted in any form or by any means without the prior written permission of 2 Minute Medicine, Inc. To license this content, contact 2 Minute Medicine, Inc. This article is for informational and educational purposes only; it is not medical advice and does not replace the judgment of a qualified healthcare professional.
Image: © 2 Minute Medicine